J Clin Pharmacol
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH
QUICK SEARCH:   [advanced]


     

Sign In to gain access to subscriptions and/or personal tools.
First published on July 17, 2008, doi:10.1177/0091270008322035

The Journal of Clinical Pharmacology 2008;48:1014.

This Article
Right arrow Full Text (JCP OnlineFirst[PDF])
Right arrow All Versions of this Article:
0091270008322035v1
48/9/1014    most recent
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrowRequest Permissions
Right arrow Request Reprints
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Khosravan, R.
Right arrow Articles by Vernillet, L.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Khosravan, R.
Right arrow Articles by Vernillet, L.
Social Bookmarking
Add to CiteULike   Add to Complore   Add to Connotea   Add to Del.icio.us   Add to Digg   Add to Reddit   Add to Technorati   Add to Twitter  
What's this?
©© 2008 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology, 10.1177/0091270008322035

Article

The Effect of Age and Gender on Pharmacokinetics, Pharmacodynamics, and Safety of Febuxostat, a Novel Nonpurine Selective Inhibitor of Xanthine Oxidase

Reza Khosravan 1*, Michael J. Kukulka 2, Jing-Tao Wu 2, Nancy Joseph-Ridge 2, and Laurent Vernillet 3

1 Pfizer Global Research & Development
2 TAP Pharmaceutical Products Inc
3 Genentech, Inc

* To whom correspondence should be addressed. E-mail: Reza.Khosravan{at}pfizer.com.


  Abstract
Febuxostat is a novel nonpurine selective inhibitor of xanthine oxidase, which is currently being developed for the management of hyperuricemia in patients with gout. The effect of age and gender on the pharmacokinetics, pharmacodynamics, and safety of once-daily oral febuxostat 80 mg was assessed in healthy male and female subjects after 7 days. Following multiple dosing with febuxostat, there were no statistically significant differences in the plasma or urinary pharmacokinetic or pharmacodynamic parameters between subjects aged 18 to 40 years and ≥65 years. Although unbound peak concentration (Cmax,u) and area under the concentration-time curve (AUC24,u) for febuxostat were higher in women as compared with men (31.5 vs 23.6 ng/mL, P ≤ .01, and 62.8 vs 53.9 ng•h/mL, P ≤ .05, for Cmax,u and AUC24,u, respectively), the differences were not considered clinically significant and could be largely accounted for by weight differences between male and female subjects. For pharmacodynamic parameters, even though the percentage decrease in serum uric acid 24-hour mean concentration was slightly greater in women than in men (59% vs 52%, P ≤ .01), this difference was not considered clinically meaningful. Febuxostat was well tolerated in male and female subjects in both age groups. Age or gender had no clinically significant effect on the pharmacokinetics, pharmacodynamics, or safety of febuxostat. Therefore, febuxostat does not require any dose adjustments based on age or gender.
Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to Technorati Technorati   Add to Twitter Twitter    What's this?


This article has been cited by other articles:


Home page
 Rheumatology (Oxford)Home page
N. L. Edwards
Febuxostat: a new treatment for hyperuricaemia in gout
Rheumatology, May 1, 2009; 48(suppl_2): ii15 - ii19.
[Abstract] [Full Text] [PDF]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH
Copyright © 2008 by the American College of Clinical Pharmacology